Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction

Completed

• Conditions: Abdominal Fat
• Interventions: Device: truSculpt

• Registration Number: NCT03428243
• Lead Sponsor: Cutera Inc.

Brief Summary

A long-term follow-up study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.

Detailed Description

The purpose of this investigation is to follow-up subjects who have completed participation in the Treatment Group of Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction" for the long-term (18 months) safety and efficacy of the truSculpt radiofrequency (RF) device for circumferential reduction in the abdominal and flank region.

Study Timeline

• Study Start: 2017-07-12
• Primary Completion: 2017-11-06
• Study Completion: 2017-12-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-09
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Completed participation in the Treatment Group of Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction"
2. Subject has maintained the same weight since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction", within 5% of baseline weight measurement.

Exclusion Criteria

1. Participation in a clinical trial of another device or drug in the target area since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
2. Any type of cosmetic treatment to the target area to reduce circumference since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction" e.g., radiofrequency, cryolysis or light-based treatments.
3. Any invasive cosmetic surgery to the target area, such as liposuction, since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
4. Newly diagnosed (since enrolling in Protocol C-16-TS11) significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
5. Newly diagnosed or documented (since enrolling in Protocol C-16-TS11) immune system disorders.
6. Current infection, dermatitis, rash or other skin abnormality in the treatment area.
7. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or treatment in the target area since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
8. Pregnant or currently breastfeeding.
9. As per the Investigator's discretion, any physical or mental condition which might make unsafe for the subject to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
truSculpt	truSculpt	truSculpt effectiveness after 18 months

Primary Outcome Measures

Name	Time	Method
Circumference Measurement	18 months post C-16-TS11 completion (September, 2016)	Comparison of Abdominal region Measurement in cm 18 months post-treatment with C-16 TS11 Baseline.

Secondary Outcome Measures

Name	Time	Method
Device Safety	18 months post C-16-TS11 completion (September, 2016)	Measurement of Resolved Adverse Events from Radiofrequency (RF) treatment (C-16-TS11), and Presence of any Additional AE within 18 months of RF treatment.

Trial Locations

Locations (1)

Cutera Research Center; 🇺🇸 Brisbane, California, United States